510(k) Report

FDA applicant

Scole Engineering Co.

Walker, MI4 decisions1977–19940 recalls

FDA records 4 decisions for Scole Engineering Co. (Walker, MI) from 1977 to 1994: 4 510(k) clearances. All are in product code DSH (Recorder, Magnetic Tape, Medical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Scole Engineering Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scole Engineering Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scole Engineering Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSHRecorder, Magnetic Tape, Medical3decisions

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K923664Scole 300 Ecg RecorderScole Engineering Co. · 19942cite it

What has FDA decided for it lately?

  • K923664Scole 300 Ecg RecorderScole Engineering Co. · 1994
  • K822362Alta II Ecg RecorderScole Engineering Co. · 1983
  • K822363Alta Iii Ecg RecorderScole Engineering Co. · 1982
  • K770829Recording Unit, Model 1445Scole Engineering Co. · 1977

All 4 as Scole Engineering Co. →